FDAClass IIOctober 9, 2019

Ketamine in 0.9% Sodium Chloride recall: Sterility Concern

Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 mg/mL) 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of…

Why was Ketamine in 0.9% Sodium Chloride recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots remaining within expiry.

Product
Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 mg/mL) 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of…
Recalling firm
KRS Global Biotechnology, Inc
Quantity
11733 syringes
Distribution
Nationwide
Recall date
October 9, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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